Home-based Proprioceptive Neuromuscular Facilitation for Subjects With Type 2 Diabetes Mellitus

January 28, 2019 updated by: National Cheng-Kung University Hospital

Effects of a Home-based Proprioceptive Neuromuscular Facilitation in Conjunction With Tendon Gliding Exercises on Sensorimotor Function in Upper Extremity of Subjects With Type 2 Diabetes Mellitus

In this research work, the concept of strengthening technique of proprioceptive neuromuscular facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve neuromuscular function of upper extremity of patients with diabetes mellitus. The first specific aim of the study is to examine the effects of home-based PNF exercise on the motor, sensation and functional performance parameters of upper extremity of the patients with diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the home-based PNF exercises can provide better treatment effects for the patients with diabetes mellitus will also been investigated in this study. One of the hypothesis of this study is the prescribing home-based PNF exercise program has a positive treatment effect on neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular function of the upper extremity of patients with diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng-Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Study participants will include clinically defined diabetic patients who are diagnosed based on the 1997 criteria of the American Diabetes Association. The inclusion criteria of the enrolled subjects are who suffered from neuropathy as diagnosed by abnormalities in either a nerve conduction study and / or quantitative sensory testing.

Exclusion Criteria:

  • DM patients with (1) traumatic nerve injuries of the upper limbs, (2) trauma to the hand or congenital anomalies of the wrist and hand, (3) skin infections or disease, (4) known vascular complications of diabetes, such as stroke may have compromised the physical integrity of the patient, (5) grade 2 or higher arterial hypertension (>160/100 mmHg) or (6) cognitive deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PNF exercise program group
The PNF home-program exercise group: perform grade 1&2 two times a day, at least 3 times per week, for 3 sets of 12 repetitions to increase neuromuscular and musculoskeletal endurance. (Grade 1: The participants performs the diagonal- spiral pattern that will enhance the strength or movement of a targeted muscle or muscle group.; Grade 2:The participants performs PNF exercise with elastic bands . )
Behavioral: lifestyle changes
Providing a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus.
Experimental: PNF in conjunction with tendon gliding exercise group
Patients in PNF in conjunction with TGE group will perform PNF grade 1&2 as well as tendon gliding exercise two times a day, at least 3 times per week, for 3 sets of 10 repetitions. Training duration for both the two groups is twelve weeks.
Behavioral: lifestyle changes
Providing a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine the touch-pressure threshold of the hands
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Nerve conduction study (NCS) at 12 weeks
Time Frame: pre-intervention (week 0) and follow-up evaluation (week 24)
determine nerve condition through detection of the amplitude of the sensory and motor nerve action potential
pre-intervention (week 0) and follow-up evaluation (week 24)
Change from baseline result of pinch-holding-up activity test at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
sensorimotor control of a hand
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Purdue pegboard test at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine fine fingertip dexterity
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine unilateral and bilateral gross motor coordination of upper extremity
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Manual tactile test at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine active touching sensation
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline result of Grasp and pinch power at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Grip strength of the hands will be assessed with a Jamar dynamometer
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of pinch power at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Pinch power is measured with a pinch gauge
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Peak force of shoulder flexion (N) will be measured
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Peak force of shoulder internal rotation (N) will be measured
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Peak force of shoulder external rotation (N) will be measured
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Peak torque of shoulder external rotation (N⋅m) will be obtained
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Time Frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Peak torque (PT) of shoulder internal rotation (N⋅m) will be obtained
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-ER-105-257

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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